Letters
Pharmacology
Volume 187 - Issue 10

MIMS is not a stand-alone resource

Author:  David T Graham

Med J Aust 2007; 187 (10): 596-597. || doi: 10.5694/j.1326-5377.2007.tb01432.x
Published online: 19 November 2007
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In reply: An article by Stockigt1 and follow-up correspondence from Mallows raised concerns about the limitations of approved product information (PI).

The purpose of PI needs to be realised. The document is not intended to act as a textbook of medicine or general management of patients, but is intended to contain sufficient information to allow a health professional, in average circumstances, to use the specified medicine safely and to refer to other sources of information and expertise should they be required. The PI covers uses of the medicine evaluated and approved by the Therapeutic Goods Administration (TGA).

The sponsor of the medicine is responsible for maintaining the PI, and the TGA has procedures in place to support their timely updating. On occasions, the TGA initiates reviews of PI when a need is identified.

Health professionals, especially specialists, are important in identifying possible improvements in PI, based on their experience, knowledge or awareness of current medical practice. The TGA encourages physicians who have suggestions to approach the sponsor of the medicine or the TGA.

It is not possible to address in detail the article by Stockigt1 or the letter by Mallows. The thyroid PI documents have been reviewed by the sponsor companies, and changes have been made where evidence supports this.

However, as indicated above, there are limitations on the role of PI. Mallows raises the issue of complex management instructions on overdosage, including the specifics of bicarbonate administration for potential metabolic acidosis. The PI documents for the named products do mention that overdose patients are likely to develop such complications, and that they require admission to hospital and management by appropriate specialists; intensive care admission is recommended in several of the documents. It is arguable how much further detail is required. The PI cannot replace careful consideration of the individual circumstances of the patient combined with expert knowledge of patient management.

PIs are complex documents. The TGA is currently considering the format of the PI and whether it can be rearranged to better balance provision of basic messages and more complex material in separate presentations.

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